Noninvasive spinal stimulation to improve walking in hereditary spastic paraplegia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Participants will receive transcutaneous spinal cord stimulation (tSCS) through self-adhesive electrodes placed on the skin over the lower back without any surgery. Treatments are delivered twice weekly for eight weeks, with each session lasting about one hour, followed by an additional eight-week no-stimulation follow-up to track durability of any changes. Researchers will measure walking speed, walking endurance, muscle stiffness, overall disease severity, and explore effects on bladder/bowel function and muscle strength. The intervention is noninvasive and designed to be combined with participants' usual assistive devices and stable medications.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Clinical diagnosis of hereditary spastic paraplegia (genetic confirmation if available).
* Stable medications for spasticity and other neurologic symptoms for =4 weeks prior to enrollment.
* Able to participate in study visits and assessments with or without assistive devices.
* If ambulatory: able to walk at least 10 meters with or without an assistive device.
* If wheelchair user: able to perform seated mobility tasks and transfers required for assessments.
* Capacity to provide informed consent and follow study procedures, with an ability to communicate and understand instructions in English

Exclusion Criteria:

* Implanted electronic devices (e.g., pacemaker, deep brain stimulator, intrathecal pumps).
* Severe cardiopulmonary disease that would make participation unsafe.
* Open skin lesions or severe dermatologic conditions at electrode sites.
* Pregnancy or plans to become pregnant during the intervention period.
* Diagnosed with Primary Lateral Sclerosis (PLS) or another neurological condition that affects walking, such as stroke, multiple sclerosis (MS), or a recent surgery on legs.
* Unable to participate in basic movement or mobility assessments, even with their usual mobility device (such as a wheelchair, walker, or cane). People who use wheelchairs or other mobility aids can participate if they can complete the study's mobility assessments in their usual way.
* Cognitive or psychiatric conditions that make it difficult to give informed consent or follow study instructions.
* Diagnosed with Urinary Tract Infection (UTI), either acute or ongoing, before or at the time of study enrollment.
* Diagnosed with epilepsy.
* Participation in another interventional clinical trial that could affect mobility or spasticity during the study.
* A recent change (within the last 4 weeks) in medications or treatments that affect spasticity or movement (for example: baclofen, tizanidine, botulinum toxin injections).
* Expect to start or change treatments for spasticity or mobility during the study period.
* Any condition judged by the investigator to pose excess risk or confound outcomes.

Where it's running

• University of Kentucky
  Lexington, Kentucky, United States Recruiting

Study contacts

• Principal investigator: Rahul Sachdeva, PhD — University of Kentucky
• Study coordinator: Rahul Sachdeva, PhD
• Email: rahulsachdeva@uky.edu
• Phone: 8592574888

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Evaluating surgical treatment for foot deformities in hereditary spastic paraplegia

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• Exploring intrathecal baclofen treatment for hereditary spastic paraplegia

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• Robot-assisted walking treatment for hereditary spastic paraplegia

  This study is testing whether using a robot to help with walking, along with regular physical therapy, can improve movement and quality of life for people with hereditary spastic paraplegia.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.